Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

NCT04085458 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 197642018-003655-37
• Study Type: interventional
• Target: 32
• Locations: 7 countries
• Sites: 13

Brief Summary

The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (1)

• FVIII Inhibitor Development by the Nijmegen Bethesda Assay

  FVIII inhibitor testing was performed using the Nijmegen-modified Bethesda assay. A positive inhibitor result was defined as a threshold of ≥0.6 BU/mL at the central laboratory and had to be confirmed with a second blood sample. After confirmation of the positive result, the inhibitor was to be reported as a serious adverse event (SAE).

  Observed for 100 exposure days (EDs), up to 2 years

Secondary Outcomes (3)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Observed for 100 exposure days (EDs), up to 2 years

• Development of Treatment-emergent Anti-PEG Antibodies

  Observed for 100 exposure days (EDs), up to 2 years

• Annualized Bleeding Rate (ABR)

  Observed for 100 exposure days (EDs), up to 2 years

Study Arms (1)

Severe hemophilia A patients

OTHER

Prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response.

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Interventions

Damoctocog alfa pegol (Jivi, BAY94-9027) DRUG

The recommended starting dose is every 5 days treatment (45 IU/kg)- An assessment of response to treatment will be performed at the next scheduled visit after 10-15 ED (8-10 weeks). Participants may be assigned to different dosing regimens (every 7 days or 2x/week) or continue with every 5 days regimen, according to individual bleeding tendency and needs at investigator's discretion.

Severe hemophilia A patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must ≥ 18 years of age inclusive, at the time of signing the informed consent.
• Participants with severe hemophilia A (FVIII: C\<1%)
• PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment before enrollment
• Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4)+ lymphocyte count \>200/mm\*3
• Participants who are willing to complete an eDiary
• Male participants
• Capable of giving signed informed consent

You may not qualify if:

• Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
• Platelet count \< 100,000/mm\*3
• Creatinine \> 2x upper limit of normal
• AST or ALT \> 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
• The participant has a planned major surgery.
• The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi).
• Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer ≥ 0.6 Bethesda unit (BU).
• Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.

Sponsors & Collaborators

• Bayer: lead

Study Sites (13)

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, 1527, Bulgaria

Location

MHAT Sveta Marina EAD

Varna, 9010, Bulgaria

Location

Aarhus Universitetshospital, Skejby

Arhus N, 8200, Denmark

Location

LAIKO General Hospital of Athens

Athens, 115 27, Greece

Location

A.O. Pugliese-Ciaccio

Catanzaro, Calabria, 88100, Italy

Location

A.O.U. Policlinico Umberto I

Rome, Lazio, 00161, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, 0372, Norway

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

SP Szpital Kliniczny Nr 1

Wroclaw, 50-367, Poland

Location

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario "La Paz"

Madrid, 28046, Spain

Location

Hospital Universitari i Politecnic La Fe | Hematologia

Valencia, 46026, Spain

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: September 23, 2019
• Primary Completion: May 20, 2022
• Study Completion: August 26, 2022
• Last Updated: July 27, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-07

Locations

PL (2); ES (3); IT (3); NO (1); DK (1); GR (1); BU (2)